Hybrid operating room for surgical and fixed imaging services in an ambulatory surgical center

ABSTRACT

An outpatient surgical center can include a hybrid operating room. The hybrid operating room can include at least one radiation shielded wall, a floor, and a ceiling. The hybrid operating room can also include an imaging device disposed in the hybrid operating room. The hybrid operating room can further include an operating table disposed in the hybrid operating room. A building for the outpatient surgical center can initially be constructed to conform to International Building Code (IBC) Class B standards.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/246,931, filed Jan. 14, 2019, which is a continuation of U.S.application Ser. No. 15/138,134, filed Apr. 25, 2016 (now U.S. Pat. No.10,180,008), which is a continuation-in-part of U.S. application Ser.No. 14/560,789, filed Dec. 4, 2014 (now U.S. Pat. No. 9,322,188), and acontinuation-in-part of U.S. application Ser. No. 14/560,721, filed Dec.4, 2014 (now U.S. Pat. No. 9,334,664), both of U.S. application Ser. No.14/560,789 and U.S. application Ser. No. 14/560,721 are continuations ofU.S. application Ser. No. 14/219,880, filed Mar. 19, 2014 (now U.S. Pat.No. 9,249,588), the entireties of which are hereby incorporated hereinby reference.

BACKGROUND Field

Various medical centers, other than hospitals, may benefit from havingcombined surgical and fixed imaging services. For example, ambulatorysurgical centers may benefit from having a hybrid operating room thatcombines such surgical and fixed imaging services.

Description of the Related Art

Combined surgical and fixed imaging services in an operating room havebeen provided only in hospital facilities. Hospital facilities aregenerally designed with a variety of special features to fulfill strictsafety requirements that add significantly to the cost to build andoperate the hospital facility. For example, hospitals are typicallyconstructed to adhere to strict building codes. Hospitals, for example,are classified according to International Building Code (IBC) asInstitutional Group 1-2, meaning occupancy shall include buildings andstructures used for medical care on a 24-hour basis for more than fivepersons who are incapable of self-preservation. Hospitals typically alsohave heightened requirements regarding fire control, such as specificrequired building materials, in part because the occupants of thehospital are often incapable of self-preservation, as noted above.

Furthermore, hospitals traditionally include a variety of equipment.Normally, a hospital includes a number of hospital beds. Similarly,hospitals typically include patient rooms, which may house thosehospital beds, and patient restrooms. Often, the size of a hospital isgiven as the number of beds the hospital has. Furthermore, hospitalsalso often include other facilities, such as a pharmacy, a lab, amorgue, and facilities providing radiology services, infectionisolation, dietary services, linen services, emergency services, and thelike.

Additionally, hospitals normally are required to have disasterprevention provisions for the primary structure and services as well asa disaster response plan, policy, and capabilities. Likewise, in view ofthe size of hospitals, hospitals often include central services (forexample, central sterilization services), materials management,environmental services, and engineering services.

According to conventional wisdom, combined surgical and imaging servicesin an operating room are best provided in a hospital context. Forexample, imaging equipment is often heavy and has substantial powerrequirements. Hospitals, with their massive infrastructure, can readilyaccommodate such requirements. Also, imaging equipment often requiresshielding due to the use of radiation, such as x-rays. Again, theinfrastructure of a hospital is conventionally thought to be the onlymedical facility infrastructure adapted to safely accommodate such apurpose. For example, the thick concrete walls and floors of a typicalhospital can help to block radiation.

Operating rooms for providing combined surgery and fixed imaging in ahospital are comparatively large. For example, a typical combinedsurgical and fixed imaging surgery room in a hospital may be in therange of 800 to 1000 square feet. For example, operating rooms in ahospital need to be of such comparatively large size in order toaccommodate the performance of up to twenty to thirty different surgicalspecialties and sub-specialties as may normally be performed in ahospital, such as cardiac, thoracic, vascular, obstetrics,gynecological, orthopedic, podiatric, urologic, otolaryngologic,neurosurgery, trauma, ophthalmology, gastrointestinal, transplant,general surgery, colorectal surgery, hand surgery, endocrine surgery,breast surgery, plastic surgery, head and neck surgery, surgicaloncology, pediatric surgery, spine surgery, oral maxillo facial surgeryand so on.

Furthermore, hospitals typically are required to have particularlyrobust infectious vector isolation as well as high quality andsophisticated nurse call systems. Hospitals also have requirements forcontrol of airborne sound transmission and water temperaturerequirements. Hospitals also normally have medical gas systems withstrict requirements on their number and amount of testing. Likewise,elevators in hospitals are required to be large to accommodate gurneytraffic.

As mentioned above, hospitals typically have specific fire coderequirements. For example, hospital construction materials must benon-combustible and must provide for patient and staff safety in case ofan emergency. Because hospitals are viewed as essential in case of adisaster, hospitals must be able to withstand greater events, such asearthquakes, floods, and the like. The structure also needs to bedesigned to provide the option of defending the structure in placerather than evacuating the structure.

To support such objectives, hospitals may be required to have redundancyof critical services, such as heating, ventilation, and air conditioning(HVAC), power, water supply, water heating, and the like. Furthermore,the materials from which the building is constructed, including thefinishes for interior walls and ceilings, must comply with strict firerequirements, such as a very low flame spread index. Other similarreinforcements and protections may likewise be required. In short, ahospital is normally required to have a significantly enhancedinfrastructure.

By contrast, conventional ambulatory surgical centers (ASCs) can beconstructed in office buildings. These buildings have various coderequirements, but typically these requirements are much less strict, andtherefore, can be fulfilled with significant cost savings as compared tothe cost to build a hospital. For example, an IBC class B structure,which may house an ASC, will have significantly less strict constructionrequirements than an IBC class 1-2 structure, typically associated withthe construction of a hospital. Similarly, the air change requirementsfor ASCs and other requirements may be much less strict for ASCs thanfor hospitals. In this discussion, class B can refer to use andoccupancy classification, such as described in International BuildingCode (2012 version), Chapter 3, section 304, “Business Group B.”

Likewise, ASCs typically do not require a pharmacy, a lab, a morgue,linen services, dietary services, and the like. Indeed, ASCs normally donot have any hospital beds, because it is not expected that the patientswill be staying overnight.

Similarly, typical operating rooms in ASCs may be smaller than inhospitals. For example, an operating room in an ASC may be less than 600square feet and possibly as small as 425 square feet. Furthermore, anASC may generally offer only one to ten different surgical specialties,rather than the twenty to thirty surgical specialties offered in atypical hospital.

ASCs can herein or otherwise be described in various ways. For example,ASCs can also be referred to as ambulatory surgery center, clinics,outpatient surgical centers, and the like. Thus, herein or otherwise theterm ASC can refer generally to ASCs, clinics, outpatient surgicalcenters and similar structures.

Office-based labs (OBLs) are another kind of non-hospital building inwhich medical procedures may be performed. OBLs may be limited as to thetype of procedures that can be performed. For example, generalanesthesia cannot be provided in an office setting in most states.Additionally, an office may lack the ability to provide an environmentthat prevents infection. Likewise, the use of an OBL may be limited tothe physician's specialty of practice.

As an example, safely placing a patient in a prone position on theoperating room table may not be possible in an office, as the ability toprotect the airway is significantly impaired and may require placementof a breathing tube. Such placement of a breathing tube may, for safetyreasons, require an ambulatory surgery center.

Most procedures performed in an OBL do not require general anesthesia,can be performed without an incision and are relatively short induration. OBLs are typically established by cardiologists and paingroups, as their procedures do not require general anesthesia and may beperformed percutaneously. Because OBLs do not require separate licensurethey are not required to have back up power resources to permitcontinued surgery and recovery of patients. Moreover, such OBLs caninclude procedure rooms, as opposed to operating rooms, with typicallyone procedure room.

Typically a given OBL would be used by a limited number of physiciansfocused on a specific area of medicine: pain, cardiology, and so on. Inaddition, registered nurses are not required in the care of a patient insuch an environment. Given that separate licensure is not required, thedesign of an OBL is not reviewed by a licensing body and is dictated bythe space of the physician's environment and needs. It is not unusualfor a medical practice to combine several exam rooms into a procedureroom.

Since most OBLs have procedure rooms, they have structural andenvironmental differences from an operating room as defined in“Guidelines for Design and Construction of Hospitals and OutpatientFacilities.”

Operating rooms may have various differences from procedure rooms.Operating rooms are typically located in a restricted area, havemonolithic floors, walls and ceilings that are scrubbable and resistantto cleaning chemicals, have their own dedicated air handlers to preventrecirculation of air, have positive pressure ventilation to prevententry of external air into the operating room, and have back up power topermit continuity of surgery in the operating room. Procedure rooms aretypically located in an un-restricted or semi-restricted area, tend tohave drop grid ceilings, may have tiled flooring, typically do not havea separate air handler, and have no specific ventilation requirements.

The national practitioner identifier program identifies ASCs with aseparate taxonomy. ASCs have a specific taxonomy code of 261QA1903X asspecified in the National Provider Identifier (NPI) by the Centers forMedicare and Medicaid Services (CMS) under the National Plan andProvider Enumeration System (NPPES). General Acute Care Hospitals havethe taxonomy code of 282N00000X. Physicians' offices, OBLs, andIndependent Diagnostic Testing Facilities (IDTFs) have taxonomy codesspecific to their specialty such as Family Medicine-207Q00000X, InternalMedicine-207R00000X, Cardiovascular Disease-207RC0000X, DiagnosticRadiology-2085R0202X. ASCs are also distinguished by their place ofservice code “24”, whereas as hospitals are place of service code “22”,and an office is place of service code “11”.

SUMMARY

According to certain embodiments of the present invention, an outpatientsurgical center can include a hybrid operating room. The hybridoperating room can include at least one radiation shielded wall, afloor, and a ceiling. The hybrid operating room can also include animaging device disposed in the hybrid operating room. The hybridoperating room can further include an operating table disposed in thehybrid operating room. A building for the outpatient surgical center caninitially be constructed to conform to International Building Code (IBC)Class B standards.

In certain embodiments of the present invention, a method ofmanufacturing an outpatient surgical center can include building ahybrid operating room. The hybrid operating room can include at leastone radiation shielded wall, a floor, and a ceiling. The method can alsoinclude shielding the at least one wall with radiation shielding. Themethod can further include installing an imaging device disposed in thehybrid operating room. The method can additionally include installing anoperating table disposed in the hybrid operating room. The building caninclude constructing the outpatient surgical center from a buildinginitially constructed to conform to International Building Code (IBC)Class B standards.

A building, according to certain embodiments of the present invention,can include a hybrid operating room. The hybrid operating room caninclude radiation shielding. The hybrid operating room can also includean imaging device disposed in the hybrid operating room. The hybridoperating room can further include an operating table disposed in thehybrid operating room. The building can include 50,000 square feet orless of floor space.

A building, in certain embodiments of the present invention, can includea hybrid operating room. The hybrid operating room can include radiationshielding. The hybrid operating room can include an imaging devicedisposed in the hybrid operating room. The hybrid operating room canalso include an operating table disposed in the hybrid operating room.The building can include an outpatient surgical center.

An outpatient surgical center can include, according to certainembodiments, a plurality of hybrid operating rooms connected by ahallway. Each hybrid operating room of the plurality of hybrid operatingrooms can include at least one radiation shielded wall, a floor, and aceiling Each hybrid operating room of the plurality of hybrid operatingrooms can include an imaging device disposed in the hybrid operatingroom. Each hybrid operating room of the plurality of hybrid operatingrooms can include an operating table disposed in the hybrid operatingroom.

BRIEF DESCRIPTION OF THE DRAWINGS

For proper understanding of the invention, reference should be made tothe accompanying drawings, wherein:

FIG. 1 illustrates a cross-section of an ambulatory surgical centeraccording to certain embodiments of the present invention.

FIG. 2 illustrates a method of manufacturing an ambulatory surgicalcenter, according to certain embodiments of the present invention.

FIG. 3 illustrates a cross-section of another ambulatory surgical centeraccording to certain embodiments of the present invention.

DETAILED DESCRIPTION

According to certain embodiments of the present invention, combinedsurgical and fixed imaging services in an operating room can be providedin an ambulatory surgical center, outpatient surgical center, or thelike, which can be collectively referred to as an ambulatory surgicalcenter (ASC).

A difference between an ASC and a medical office, such as a doctor'soffice, may be the ability to charge a facility fee for reimbursement ofuse of the ASC. Another difference may be the ability to obtain Medicareaccreditation as an ASC according to a government, for example theability to obtain Medicare accreditation under the federal definition ofan ASC. Similarly, a further difference may be the ability to obtain alicense as an ASC and/or to obtain architectural review/approval of thebuilding as an ASC. Licensure and architectural review/approval may bestate dependent. In contrast with an ASC, there may not be specificdesign requirements for a medical office in which surgery may beperformed. In certain cases, non-Medicare insurances may recognize aparticular facility as an ASC for reimbursement purposes, unlike amedical office in which surgery may be performed.

Typical building differences from a medical office may be that ASCs forMedicare and for most states may be required to meet Medicare lifesafety codes and American Institute of Architects (AIA) guidelines,whereas medical offices may have no such requirements. Other guidelinesmay include the Facility Guidelines Institute (FGI) “Guidelines forDesign and Construction of Hospitals and Outpatient Facilities” from2010 or the update of those guidelines in 2014. Other standards mayinclude National Fire Protection Association (NFPA) codes.

There may be other differences. For example, the ceilings of theoperating rooms in an ASC may be monolithic.

FIG. 1 illustrates a cross-section of an ambulatory surgical centeraccording to certain embodiments. As shown in FIG. 1, an ambulatorysurgical center 100 can include a hybrid operating room 105. The hybridoperating room 105 can include one or more lead-shielded walls 110. Onlytwo walls are shown in the cross-section view, but two more may beorthogonal to those illustrated. The hybrid operating room may alsoinclude a floor 115 and a ceiling 120. Shielded doors, not illustrated,may also be provided in the lead-shielded walls. Other shieldingmaterials besides lead are also permitted in certain embodiments. Thosedoors may lead to a hallway or to other rooms including additionalhybrid operating rooms.

There can be lead-shielded walls 110, which are shielded to a height ofless than a predetermined limit, e.g., eight feet. Thus, thelead-shielded walls 110 may be shielded to a height that is lower thanthe height of the ceiling 120, such as to a height of at least sevenfeet. Other heights are also permitted. The ceiling 120 may not, incertain embodiments, include lead shielding or any other type ofradiation shielding. This may be particularly applicable when theambulatory surgical center 100 is a single story building or when theambulatory surgical center 100 is on the top floor of an officebuilding. By contrast, in other embodiments the ceiling 120 may beshielded. For example, such shielding may be provided when theambulatory surgical center 100 is located on a lower floor of amulti-story building.

Similarly, the floor 115 can be shielded or unshielded, according to thelocation of hybrid operating room 105 with respect to the rest of theambulatory surgical center 100 or building. For example, when theambulatory surgical center 100 is on a second floor, the floor 115 maybe shielded (with lead or other radiation shielding material), whereaswhen the ambulatory surgical center 100 is on a ground floor or in abasement, it may not be necessary to shield the floor 115. In a basementit may not be necessary to provide any additional shielding to one orany of the walls.

In certain embodiments, the floor 115 may be reinforced. For example, ifa multistory building is used, and the hybrid operating room 105 isinstalled in a second story of the building, the floor 115 of the hybridoperating room 105 may be modified in various ways, such as to provideconduits or shielding, but also to provide additional support forimaging or other equipment in the hybrid operating room 105.

A material can be considered as shielding if it provides adequateprotection to humans who are on the side opposite the material from theradiation source. The adequacy of the protection may depend on factorssuch as what is deemed a safe exposure level and depending on anexpected dwell time of a human on the other side of the shielding. Theadequacy of the protection may also depend on the type of radiation usedin the imaging. For example, in the case of MRI, copper shielding may besuitable because radio frequency is the type of radiation being used.

The ambulatory surgical center 100 can also include an imaging device125 a, 125 b disposed in the hybrid operating room 105, for example in acentral area of the hybrid operating room 105. The ambulatory surgicalcenter 100 can further include an operating table 130 disposed in thehybrid operating room 105, for example in the central area of the hybridoperating room 105. The operating table 130 is shown without legs due tothe cross-sectional view, but the operating table 130 may have legs,wheels, or the like. The operating table 130 may be in a fixed positionor may be capable of movement, for example, to position a patient.

The imaging device 125 a, 125 b can be or include a fluoroscopy device.The fluoroscopy device can include a fixed C-arm device with the abilityto perform, among other things, cineradiography (CINE) and digitalsubtraction. A CAT scan or Mill device may be used instead of or inaddition to a fluoroscopy device as an imaging device. The imagingdevice 125 a, 125 b can include a radiating component 125 b fixed to thefloor 115 or ceiling 120 and a monitor component 125 a fixed to theceiling 120. Alternatively, the monitoring component 125 a can be fixedto the floor 115. In other embodiments the monitoring component 125 aand the radiating component 125 b, or either of the components, can befixed to one or more of the walls.

The ambulatory surgical center 100 can further include an equipment room135 adjacent to the operating room. The equipment room 135 can include apower supply 140 for the imaging device 125 a, 125 b. The ambulatorysurgical center 100 can include one or more conduit(s) 145 a, 145 b fromthe equipment room 135 to the imaging device 125 a, 125 b configured todeliver power to the imaging device 125 a, 125 b.

A power room may broadly refer to any room with power electronics, powerconditioning, or the like. In certain embodiments, a power room can alsobe an equipment room, for example, a room in which various equipment maybe provided in association with the operating room including any deviceused in the operating room. Alternatively, a power room may be distinctfrom an equipment room. Thus, portions of the electronics for theimaging device 125 a, 125 b may be provided in cabinets (or in otherarrangements) in equipment room 135. The equipment room 135 may includea step-down transformer, filters, uninterruptable power supplies, orother equipment that may support the use of the operating room. Thisequipment room 135 may be in addition to a room in the building intowhich a main electrical line for the building comes and from which themain electrical line is branched out to various parts of the building.This additional room may provide circuit breakers for the building, forexample. This additional room can also be considered a power room, butmay--in certain embodiments--be in addition to equipment room 135.

The conduit(s) 145 a, 145 b can be located beneath the floor 115 (forexample, at 145 b), above ground, or above the ceiling 120 (for example,at 145 a). An above-ceiling conduit 145 a may provide power to elementsthat are not attached to the floor (such as monitor element 125 a),while the below floor-surface conduit 145 b can provide power toelements that are attached to the floor (such as radiating component 125b), or which are held in place by gravity. An in-wall conduit (notshown) can likewise be used for equipment, for example if the equipmentis attached to a wall. The conduit(s) 145 a, 145 b can also provide oneor more data paths to imaging equipment or other computers in the hybridoperating room.

The equipment room 135 and/or the power supply 140 can be configured toprovide power employing a variety of possible voltages. In certainembodiments, the equipment room 135 and/or the power supply 140 can beconfigured to provide power employing at least 480 VAC or at least 208VAC. In other embodiments, the equipment room 135 may provide 120 VAC.Other voltages are also permitted. Furthermore, the equipment room 135may include a step-up transformer 155 configured to provide the desiredpower, such as the 480 VAC, 208 VAC or any other desired power. Astep-down transformer, not illustrated, may also or alternatively beprovided. Other power conditioning or reliability circuitry, such asfilters, uninterruptible power supplies, generators, or the like mayalso be provided. The equipment room may be configured to house computerequipment and may be provided with one or more conduits to the hybridoperating room or to another room in the building, such as to a roomhousing circuit breakers for the building.

In certain embodiments, the power may come directly from a room housingthe circuit breakers. Likewise, in certain embodiments the step-uptransformer 155 may be provided in a room housing the circuit breakers.

The ambulatory surgical center 100 can additionally include an emergencypower source 145 for the imaging device 125 a, 125 b configured topermit continuity of surgery in the hybrid operating room 105 during apower outage. The emergency power source 145 may be, for example, agenerator, an uninterruptable power supply, or another source of powerdifferent from the power used in a non-emergency setting. The emergencypower source 145 may be configured to supply emergency power to otherdevices or aspects than just the imaging device 125 a, 125 b. Forexample, the emergency power source 145 may be configured to supply acritical power bus or critical power panel for multiple devices. Theemergency power source 145 may be optional, and, in certain embodiments,may provide one or more levels of quality of emergency power. Forexample, the emergency power source 145 may provide a first level ofquality of emergency power sufficient to permit safe shutdown ofadministrative or non-essential computer systems, and a second level ofquality of emergency power sufficient to permit a safe conclusion ofsurgery relying on one or more computer system, robotics system, medicalsystem, and/or imaging system.

The ambulatory surgical center 100 can also include equipment 150configured for the supply and provision of medical gasses. The medicalgasses can include anesthetic gasses, such as nitrous oxide, as well asoxygen. The medical gasses equipment 150 can also provide suction.Accordingly, the medical gasses equipment 150 can be attached toplumbing in the wall (not illustrated), as well as to a waste trap (notillustrated). In certain embodiments of the present invention, thisplumbing may lead to a central medical gas room, from which gas andsuction are provided to a plurality of hybrid operating rooms likehybrid operating room 105.

The ambulatory surgical center 100 can further include an air changesystem 160. The air change system 160 can be configured to provide aminimum or maximum number of air changes per hour or any desired airchange rate therebetween. For example, the minimum number of air changesper hour may, in certain embodiments of the present invention, be six,ten, fifteen, or twenty room air changes per hour or any other desiredrate.

The air change system 160, equipment 150 for the supply and provision ofmedical gases, equipment room 135, emergency power source 145, andconduits 145 a, 145 b may be configured to support a plurality ofoperating rooms. For example, an equipment room 135 may be locatedbetween two or amongst three or more operating rooms. In otherembodiments, each operating room may have its own dedicated equipmentroom 135.

Other rooms may also be provided. For example, a control room can beprovided. The control room may be used by ancillary staff. The controlroom may be shielded from radiation produced in the hybrid operatingroom. The room can include a leaded glass window or other ways ofpermitting the ancillary staff to view the hybrid operating room. Forexample, a closed circuit television system may be installed in thehybrid operating room with communications channel(s) provided to thecontrol room.

Other equipment may be used as well. For example, a robotic c-arm may beused. This robotic c-arm may be controlled from the control room, incertain embodiments. In certain embodiments, the monitor portion of theimagining equipment may be provided in a control room or other remotelocation, either instead of or in addition to having the monitor portionprovided in the operating room. Such a setup may be used in cases wherethe hybrid operating room is being used in combination with varioustelemedicine techniques.

The ambulatory surgical center 100 can include a wooden frame buildingstructure. For example, the ambulatory surgical center 100 can beconstructed according to building codes that are suitable to an officebuilding. For example, the ambulatory surgical center 100 can beconstructed to conform to International Building Code (IBC) Class Bstandards (or such other standards permitting the use of combustibleconstruction materials). In certain embodiments, the building mayinitially be constructed according to Class B standards but maysubsequently be modified to other standards, in whole or in part. Incertain cases, a class I structure may be used as an ambulatory surgicalcenter.

Various embodiments of the present invention may include a variety ofoptions. For example, a building according to certain embodiments mayinclude an ambulatory surgical center or medical office. The ambulatorysurgical center or medical office can include at least one hybridoperating room, and optionally several hybrid operating rooms. Thehybrid operating room(s) can each include at least one wall that isconfigured to shield radiation, a floor, and a ceiling.

Each hybrid operating room can include an imaging device disposed in acentral area of the hybrid operating room. An Mill, CT scan, or similardevice can be the imaging device. Rather than, or in addition to theimaging device, the room can include a device such as a gamma knife.

Each hybrid operating room can include an operating table disposed inthe central area of the hybrid operating room. Optionally, one or moreadditional operating tables can be provided in the central area.

The ambulatory surgical center or medical office can include a powerroom/equipment room adjacent to the operating room. Alternatively, thepower room and/or equipment room can be nearby the operating room, suchas one or two rooms away from the hybrid operating room. The power roomand/or equipment room can include a power supply for the imaging device.

The ambulatory surgical center or medical office can include a conduitfrom the power room/equipment room to the imaging device configured todeliver power to the imaging device. The conduit can also oralternatively include control cabling, data cabling, or other cabling.

The ambulatory surgical center or medical office can further include aconduit from the equipment room and/or power room to a control roomand/or control desk. The conduit can include control cabling, datacabling, or other cabling. For example, the conduit can carry a videosignal corresponding to a monitor of the imaging device. Thus, theconduit can be a conduit from the imaging device to the control roomand/or control desk.

The ambulatory surgical center and/or medical office can also include,above the ceiling, structural support for the weight of a surgicallight, imaging device, suspension of lead shielding to protect theoperating physician from radiation, contrast injectors, and/or boom.

The ambulatory surgical center and/or medical office can also include amonolithic ceiling that is scrubbable and resistant to chemicalcleaners. The ceiling can be equipped with cleaning equipment, such asradiators, sprayers, ultraviolet (UV) lights, or the like.

The ambulatory surgical center and/or medical office can also include amonolithic floor that is scrubbable and resistant to chemical cleaners.The monolithic ceiling and/or the monolithic floor can also be resistantto other kinds of cleaners, such as gamma radiation or ultravioletlight.

The ambulatory surgical center and/or medical office can includeemergency power source. The emergency power source can be configured toprovide power for any additional equipment in the room necessary tocontinue surgery such as surgical lighting, anesthesia equipment, airconditioning, heating, monitors, and so on, in addition to the imagingdevice itself.

The ambulatory surgical center and/or medical office can be a singlestory building. For example, the ambulatory surgical center and/ormedical office can be initially constructed as a single-story officebuilding. The ambulatory surgical center can be a freestanding buildingas opposed to a multi-tenant building.

The ambulatory surgical center and/or medical office can be provided ina building composed of combustible materials or built with substantialamounts of such materials. For example, the ambulatory surgical centerand/or medical office may be a wood-frame building. The building may bea class III, IV, or V IBC construction type. The building may be from,for example, about 4,000 square feet to about 20,000 square feet.

The building can be designed for the occupants to stay for less than 24hours. The building can be designed to facilitate evacuation in case offire or other emergency, as opposed to being designed to permitsheltering in place.

The building may be built or modified such that a license is obtained tooperate as an ASC.

The building can include two or more hybrid operating rooms. The roomscan be configured such that if there is an equipment failure in oneroom, a medical procedure can be transferred to the other room to avoidcancellation of the procedure.

Other buildings and construction types can also be used. For example,modular buildings or other prefabricated buildings, including buildingsdelivered as trailers such as double-wide trailer may be usable incertain embodiments. In such cases, the shielding requirements maydepend on the location where the modular building is going to beinstalled. In certain embodiments, the modular building withoutradiation shielding installed can be shipped to a location and theradiation shielding can subsequently be added. In other embodiments, theradiation shielding can be installed in the modular building prior toshipping them to a final installation location. Although such buildingsmay be modular and may be delivered by trailer, the buildings may bestationary and fixed in position once they are finally assembled anddeployed.

For example, in certain embodiments, the ambulatory surgical center canbe adjacent to an office such as a medical office and separated from theoffice by at least one firewall. Thus, for example, in certainembodiments a firewall and other upgrades can be added to an existingoffice building or to a building otherwise constructed as suitable foroffice building usage. In certain embodiments, the ambulatory surgicalcenter may, for example, be in a strip mall or in another structurewhere a wall is shared with another business, which business may nothave anything to do with medical care. For example, the other office maybe restaurant and the firewall may separate the ambulatory surgicalcenter or part of that center from the restaurant. In other cases, anambulatory surgical center may be separated from a related medicaloffice or other parts of a building not related to the ambulatorysurgical center, by a firewall.

In certain embodiments of the present invention, the ambulatory surgicalcenter 100 may not be adjacent to or within a hospital. Indeed, incertain embodiments of the present invention, the ambulatory surgicalcenter 100 may not be in close physical proximity to a hospital.Additionally, the ambulatory surgical center 100 may not be affiliatedwith any hospital.

The ambulatory surgical center 100 may not itself be a hospital.Furthermore, the ambulatory surgical center 100 can exclude an inpatientroom configured to permit a patient to stay for more than twenty-threehours. The ambulatory surgical center may not include any rooms equippedwith hospital beds. Similarly, the ambulatory surgical center 100 can beoperated by medical professionals and medical support staff exclusivelydedicated to providing not more than a predetermined number of surgicalspecialties, e.g., 5 or 10 or any number there between, of medicalprocedures in the ambulatory surgical center 100. Furthermore, theambulatory surgical center 100 can be 50,000 square feet or less offloor space, for example, 40,000 or 20,000 square feet or less in termsof its floor space. Moreover, in certain embodiments, the hybridoperating room can be installed in a building that has 50,000 squarefeet or less of floor space, for example, 40,000 or 20,000 square feetor less, but which may not necessarily be an ambulatory surgical center.

FIG. 2 illustrates a method of manufacturing an ambulatory surgicalcenter, according to certain embodiments of the present invention. Themethod can include, at 205, building a hybrid operating room. The hybridoperating room can include one or more lead-shielded wall, a floor, anda ceiling. The building of the hybrid operating room can involveconverting an existing room into a hybrid operating room throughrenovations, or can involve building the hybrid operating room duringconstruction of a building housing the hybrid operating room.

The method can also include, at 210, shielding the walls with lead orany other suitable shielding material. The lead shielded walls can beshielded to a height of less than a predetermined limit, e.g., eightfeet. The shielding may, in certain embodiments, extend to a height ofat least seven feet. The ceiling can be unshielded. The floor can alsobe unshielded, for example, when the ambulatory surgical center is onthe ground floor of a building that does not have any basement or otherspace intended for human occupancy.

Other shielding scenarios are also possible. For example, if humans arenot normally expected to be on the other side of a wall while the hybridoperating room is in use, the walls may be unshielded. For example, ifthere were landscaping without any walkways on the other side of thewall, or if the hybrid operating room is above ground level and there isno other nearby multi-story building, in such cases shielding may beomitted from such a corresponding wall.

The method can further include, at 215, installing an imaging devicedisposed in a central area of the hybrid operating room. The imagingdevice can be or include a fluoroscopy device. The fluoroscopy devicecan be a fixed C-arm device. A computed tomography (CAT or CT) scan ormagnetic resonance imaging (MRI) device may be used instead of afluoroscopy device as an imaging device. Other imaging devices are alsopermitted.

The method can additionally include, at 220, installing an operatingtable disposed in the central area of the hybrid operating room. Theoperating table can be installed and positioned specifically to place apatient within an operational range of the fluoroscopy device.

The method can further include, at 225, building an equipment roomadjacent to the operating room. The building of this equipment room canbe a matter of renovating an existing office building structure, incertain cases. The building can involve constructing the ambulatorysurgical center from a building initially constructed to conform toInternational Building Code (IBC) Class B standards, such as the 2012version of those standards or any similar standards. In certainembodiments, after renovation the portion of the building including thehybrid operating room may meet higher or stricter building standards.

The method can also include, at 230, installing, in the equipment room,a power supply for the imaging device. The power supply may be installedto receive electricity from an electric utility company (or from anyother power source, such as self-generation, diesel generator,photovoltaics, or the like), process it, and supply it to the imagingdevice. The equipment room and/or power supply can be configured toprovide power at, for example, 480 VAC. As mentioned above, othervoltage values are also possible.

The method can additionally include, at 235, installing one or moreconduit(s) configured to supply power from the equipment room to theimaging device. These conduits can be installed beneath the floor of thehybrid operating room and/or in or above the ceiling of the hybridoperating room. The conduits can additionally or alternatively beprovided in at least one wall. The conduit may supply power at a loweror different voltage than is used or received in the equipment room.

The method can further include, at 240, installing an emergency powersource for at least the imaging device configured to permit continuityof surgery in the hybrid operating room during a power outage. Thisemergency power source, if it is a generator or a set of batteries, maybe installed outside the walls of the ambulatory surgical center, andmay be connected by tie-ins to the equipment room and/or power supply.

The ambulatory surgical center can include a wooden frame building andcan be constructed to conform to International Building Code (IBC) ClassB standards (or such other standards permitting the use of combustibleconstruction materials), as described above with reference to FIG. 1.Other constructions of the frame of the building are also permitted. Forexample, the ambulatory surgical center can include a steel, concrete,or masonry frame building structure.

The method can also include, at 245, permanently fixing a radiatingcomponent of the imaging device to the floor and, at 250, permanentlyfixing a monitor component of the imaging device to the ceiling. Themonitor component and the radiating component may each include movingparts, but may be anchored to a specific location in the floor andceiling.

The method additionally may include, at 255, installing an air changesystem in the ambulatory surgical center, wherein the air change systemis configured to provide twenty room air changes per hour (or any otherdesired rate of air change).

The above method steps are described and illustrated in a particularorder. Nevertheless, this order is simply for ease of reading and doesnot imply that the steps must be performed in the listed order. Forexample, the installation of the emergency power source may not need tohave any particular order with respect to the other steps. Steps thatmust be performed under the floor, in the walls, or above the ceilingmay be performed prior to the installation of the imaging equipment andoperating table. Thus, the order of steps may be varied as desired orneeded.

FIG. 3 illustrates a cross-section of another ambulatory surgical centeraccording to certain embodiments of the present invention. FIG. 3differs from FIG. 1 in that the radiating component 125 b is shown fixedto ceiling 120 instead of the floor 115. Other implementations are alsopossible.

Certain embodiments may utilize a pre-existing office building orsimilar structure. Alternatively, certain embodiments can be provided asa kit or other modular assembly. For example, a hybrid operating roomcan be provided as a skid having pre-defined or standard interfaces toplumbing, power, medical gasses, power and signal conduits, and so on.Likewise, one or more doorways can be provided at a predetermined orstandard location.

Certain embodiments, therefore, can include a standard plug interface toan operating room (OR) to provide plumbing hookups, air handlingmanifold, gas provision manifold, electrical hookups, and the like. Thestandard plug interface can combine multiple hookups that wouldtraditionally be handled separately.

The hybrid operating room, whether implemented modularly or not, caninclude a neutralizing system for venting inhalation anesthesia or otherbio-active gasses. In addition, or alternatively, the room can includean auxiliary interface to an external vent. As a further alternative,medical gasses can be returned to another room where they can beprocessed. These venting systems may be used, for example, in connectionwith using an anesthesia machine.

The hybrid operating room, whether implemented modularly or not, caninclude an internal wall structure for support of internal OR walls. Theinternal wall structure can include a cavity for insertion of radiationshielding. The cavity may be in the form of a mold to accommodate highdensity (HD) concrete or other materials. Other materials can include,for example, shotcrete, which is described in U.S. Pat. No. 6,565,647,or other materials that include metals embedded within concrete.

Internal walls of the room can have additional provisions for ORsupport. For example, the walls can have a contaminated/dirty supplypass-through for cleanup/autoclave. This supply can be segregated fromclean/sterile supply.

Provision can also be made for endoscope handling, cleaning,sanitization, and storage in the room. Alternatively, such handling,cleaning, sanitization and storage could be performed in a nearby room.

The hybrid operating room can include a sterile supply cabinet.Optionally, this sterile supply cabinet can include a pass through forprovisioning from an adjacent or adjoining room.

The sterile pass-through can include, for example, a conveyor beltand/or dumbwaiter. The sterile pass-through can include a sterileconveyor to a sterile room. Devices/supplies can be delivered to theroom. The sterile pass-through may permit a nurse or other assistant toaid a doctor without leaving the room.

The hybrid operating room can be equipped with various cleaningfeatures. For example, there can be built-in cleanup capability. Theremay be dispersion heads provided in the walls, ceiling, or floor forcleaning gas, liquid, plasma, light or other radiation agent.Additionally, the room may be provided with an automatic vent and/orexhaust for sanitization gas. The sanitization gas venting may beseparate from the venting used for ordinary air changes.

The floor of the hybrid operating room may be provided with one or moreaccessible drains, for example in an elevated floor. The drains may beprovided with a seal or valve to prevent contamination of the roomthrough the drain when the drains are not being used.

A modular skid can potentially support several ORs in a modular fashion.For example, there can be a center section of a rose-shaped deploymentof rooms. Alternatively, a modular skid can include just a single room.

Each room may be provided with features for power supply and handling.For example, each room may include breakers, fusing, and a line supplyinterface. Moreover, each room may include a safety cutoff switchinterface. Additionally, each room may include transformers, a powersupply, and line conditioners. Each room may also include a batterypowered inverter and/or interface to external generator. Each room mayfurther include an interface to an optional solar charger. The room canalso be provided with full access for maintenance. Furthermore, theelectrical systems can be provided with a proper grounding interface.

Each room may also include various computing and other electronicprocessing and information systems. For example, each room can beequipped with or connected to a computer network and/or server(s). Amongother things, such computing devices may handle an imaging interface toOR and display/handling of data. The computing devices can include abuilt-in dedicated maintenance/inspection interface, tracking logs formaintenance, and automatic notification (for example, via email and/orshort message service (SMS)) when an issue is detected. Issues caninclude, for example, power line spikes, service outages, battery chargestate, low gas pressure, failed air handler, filter change time, or anyother configured alert. The computing device may have comprehensivesafety and operational monitoring performed automatically.

Each room may have various environmental controls. For example, the roommay include an air handler and filters for air exchange.

Each room may be configured for gas provisioning. For example, the roomcan be configured for medical gasses, such as oxygen (for example,O.sub.2), nitrous oxide NO.sub.2, and anesthetic gas mixtures. Asmentioned above, the rooms can also be configured to handle sanitizinggasses. Sanitizing gasses can include ethylene oxide, peroxides providedas aerosols, quaternary ammoniacals, or the like. The room may includesuction and a waste trap.

The room can include access for maintenance. In certain embodiments, oneor more of the walls may be a load bearing wall for shielding. In such awall, or in another wall, there can be an access panel formaintenance/provisioning, such as gas cylinder exchange for gasses forthe room.

Certain embodiments may provide a sliding horseshoe-shaped room withdeployable shield doors. For example, the room may be generallyu-shaped.

In certain embodiments, there may be an L-shaped building with onehallway, and multiple operating rooms, such as five ORs. There may becontrol room, which may be a section of the hybrid operating room or aseparate room. For example, a control room may be provided next to theoperating room or between two neighboring operating rooms. The controlroom may be, for example, about 250 to about 750 square feet.

Various imaging devices can be provided in the hybrid operating room.These imaging devices can include CAT scan, MM, PET, Thorium scans, Lexiscans, or the like. As mentioned above, gamma knives can also beincluded. Proton therapy equipment can similarly be included.

Imaging and other devices can be fixed devices or mobile devices. Forexample, a fixed C-arm can be used. The fixed C-arm can be attached tothe ceiling, to one or more of the walls, to the floor, or to anycombination thereof.

Airflow in the room can be configured to be laminar. For example, theroom can be configured to provide positive pressure in OR, being pushedfrom above. In air registers, there can be a central structural unistrutabove with a track central to the air registers so laminar flow is notbeing interrupted. Sidewall laminar flow may alternatively be providedwith air flowing across the surface of the operating table.

Certain embodiments can be designed to ensure verifiable quality carewith specific requirements, such as the American Association forAccreditation of Ambulatory Surgery Facilities (AAAASF) standards thatevery facility may need to meet. The standards may include the followingissues: general environment; operating room environment, policy andprocedures; recovery room environment, policy and procedures; generalsafety in the facility; blood and medications; medical records; qualityassessment/quality improvement; personnel; governance; and anesthesia.

Other features of the room may include adaptations to the imagingequipment. For example, the monitor for the imaging equipment may have acontactless user interface. For example, a viewer for film may permit adoctor to review various slides of film, to select a new film, to zoom afilm, and the like without contact using gestures, eye-tracking, orvoice commands.

The same contactless user interface, or a similar contactless userinterface, can be used to control the c-arm or other mounting of theimaging device or other device.

Certain embodiments may include or one more microphone and or videorecorder in the room. The recording equipment may be configured topermit a doctor to dictate an operation report as the operation isprogressing. The recording may feature a voice-to-text feature and aplayback from text feature, to permit the doctor to quickly review thetranscription.

The system may also be configured to incorporate video and/or stillimages from a video or from the imaging device itself into in theoperating report. Time stamps of the video and the dictated report maybe used to automatically align the report and video or other images.

Voice control and other contactless user interfaces can also be used tocontrol other aspects of the room. For example, such controls can beprovided for control of lights, air change, medical gasses, or the like.Any recording equipment, dictation equipment, videography equipment, orthe like may similarly be controlled without contact.

In certain embodiments the user interface may be any contactlessinterface. In addition to, or instead of that, controls can be done viaa disposable clean surface. For example, a sterile plastic bag may beprovided over each handle, screen or other contact-sensitive controlelement.

The hybrid operating room may be equipped with lighting. The lightingmay include a spectrum-controllable lighting source to assist withvisibility of surgical area. For example, red/green/blue (RGB) lightemitting diode (LED) light sources can be provided. The color balance ofthese lights may be programmable, and may be configured to assist withvisualizing certain tissues or samples. For example, a color of lightingcan be altered to assist with identifying a particular expected color inan image or tissue.

In certain embodiments there can be natural lighting enhancement throughredirected fiber-optic fixtures. There may be a light receiver outsideand a light emitter inside surgical room at desired locations, ambientdiffused or through collimated surgical light beams. Alternatively, orin addition, programmable lighting may be configured to simulate actualor desired outdoor lighting conditions, including changes in color orintensity over time.

A backup lighting source can be provided by natural illuminationrouting, such as fiber optic, waveguide, or reflector tunnel. The backuplighting source be configured to include a closable aperture to adjustambient light in the surgical center.

The above discussion provided an ASC as an example of a non-hospitalbuilding that could be configured according to certain embodiments ofthe present invention. An office-based lab (OBL) is another example ofsuch a building that may be equipped with certain embodiments of thepresent invention. A hybrid procedure room in an OBL may be equippedsimilarly to the way in which a hybrid operating room in an ASC isequipped, as described above. In certain cases, however, an OBL may notbe equipped to perform general anesthesia. Thus, for example, there maynot be a need to have a medical gasses section to the hybrid procedureroom.

One having ordinary skill in the art will readily understand that theinvention as discussed above may be practiced with steps in a differentorder, and/or with hardware elements in configurations which aredifferent than those which are disclosed. Therefore, although theinvention has been described based upon these preferred embodiments, itwould be apparent to those of skill in the art that certainmodifications, variations, and alternative constructions would beapparent, while remaining within the spirit and scope of the invention.In order to determine the metes and bounds of the invention, therefore,reference should be made to the appended claims.

What is claimed is:
 1. An ambulatory surgical center, comprising: ahybrid operating room, comprising: an imaging device fixed within thehybrid operating room; an operating table; and radiation shieldingconfigured to shield an exterior of the hybrid operating room fromradiation output from the imaging device.
 2. The ambulatory surgicalcenter according to claim 1, wherein the radiation shielding comprisesat least one radiation-shielded wall.
 3. The ambulatory surgical centeraccording to claim 1, wherein the operating table is disposed in alocation substantially central to an interior of the hybrid operatingroom.
 4. The ambulatory surgical center according to claim 1, whereinthe imaging device is fixed at a location substantially central to aninterior of the hybrid operating room.
 5. The ambulatory surgical centeraccording to claim 4, wherein the imaging device comprises a c-armdevice fixed to a ceiling of the hybrid operating room.
 6. Theambulatory surgical center according to claim 1, wherein the imagingdevice comprises at least one of a fluoroscopy device, a magneticresonance imaging device, a computed tomography device, an x-ray device,and a positron emission tomography device.
 7. The ambulatory surgicalcenter according to claim 1, wherein the hybrid operating room furthercomprises a gamma knife.
 8. The ambulatory surgical center according toclaim 1, further comprising: a medical gas room configured to provide atleast one of a gas source and a suction source to the hybrid operatingroom.
 9. The ambulatory surgical center according to claim 1, furthercomprising: a power supply configured to provide power to the imagingdevice.
 10. The ambulatory surgical center according to claim 1, furthercomprising an air change system configured to provide at least six airchanges per hour to the hybrid operating room.
 11. The ambulatorysurgical center according to claim 1, wherein the ambulatory surgicalcenter consists of not greater than 20,000 square feet.
 12. Theambulatory surgical center according to claim 1, wherein the ambulatorysurgical center is not adjacent to or within a hospital.
 13. Theambulatory surgical center according to claim 1, disposed within abuilding conforming with International Building Code (IBC) Group Bclassification standards.
 14. The ambulatory surgical center accordingto claim 1, absent any inpatient room for a stay of a patient for atleast twenty-four hours.
 15. The ambulatory surgical center according toclaim 1, comprising a plurality of the hybrid operating room.
 16. Abuilding, comprising: a hybrid operating room, comprising: an imagingdevice fixed within the hybrid operating room; an operating table; andradiation shielding configured to shield an exterior of the hybridoperating room from radiation output from the imaging device; whereinthe building conforms with International Building Code (IBC) Group Bclassification standards.
 17. The building according to claim 16,wherein the radiation shielding comprises at least oneradiation-shielded wall.
 18. The building according to claim 16, whereinthe operating table is disposed in a location substantially central toan interior of the hybrid operating room.
 19. The building according toclaim 16, wherein the imaging device is fixed at a locationsubstantially central to an interior of the hybrid operating room. 20.The building according to claim 19, wherein the imaging device comprisesa c-arm device fixed to a ceiling of the hybrid operating room.
 21. Thebuilding according to claim 16, wherein the imaging device comprises atleast one of a fluoroscopy device, a magnetic resonance imaging device,a computed tomography device, an x-ray device, and a positron emissiontomography device.
 22. The building according to claim 16, wherein thehybrid operating room further comprises a gamma knife.
 23. The buildingaccording to claim 16, further comprising: a medical gas room configuredto provide at least one of a gas source and a suction source to thehybrid operating room.
 24. The building according to claim 16, furthercomprising: a power supply configured to provide power to the imagingdevice.
 25. The building according to claim 16, further comprising anair change system configured to provide at least six air changes perhour to the hybrid operating room.
 26. The building according to claim16, further comprising a wooden frame building structure.
 27. Thebuilding according to claim 16, wherein the building is not adjacent toor within a hospital.
 28. The building according to claim 16, absent anyinpatient room for a stay of a patient for at least twenty-four hours.29. The building according to claim 16, comprising a plurality of thehybrid operating room.
 30. A medical office, comprising: a hybridoperating room, comprising: an imaging device fixed within the hybridoperating room; an operating table; and radiation shielding configuredto shield an exterior of the hybrid operating room from radiation outputfrom the imaging device
 31. The medical office according to claim 30,wherein the radiation shielding comprises at least oneradiation-shielded wall.
 32. The medical office according to claim 30,wherein the operating table is disposed in a location substantiallycentral to an interior of the hybrid operating room.
 33. The medicaloffice according to claim 30, wherein the imaging device is fixed at alocation substantially central to an interior of the hybrid operatingroom.
 34. The medical office according to claim 33, wherein the imagingdevice comprises a c-arm device fixed to a ceiling of the hybridoperating room.
 35. The medical office according to claim 30, whereinthe imaging device comprises at least one of a fluoroscopy device, amagnetic resonance imaging device, a computed tomography device, anx-ray device, and a positron emission tomography device.
 36. The medicaloffice according to claim 30, wherein the hybrid operating room furthercomprises a gamma knife.
 37. The medical office according to claim 30,further comprising: a medical gas room configured to provide at leastone of a gas source and a suction source to the hybrid operating room.38. The medical office according to claim 30, further comprising: apower supply configured to provide power to the imaging device.
 39. Themedical office according to claim 30, further comprising an air changesystem configured to provide at least six air changes per hour to thehybrid operating room.
 40. The medical office according to claim 30,wherein the OBL consists of not greater than 20,000 square feet.
 41. Themedical office according to claim 30, wherein the OBL is not adjacent toor within a hospital.
 42. The medical office according to claim 30,disposed within a building conforming with International Building Code(IBC) Group B classification standards.
 43. The medical office accordingto claim 30, absent any inpatient room for a stay of a patient for atleast twenty-four hours.
 44. The medical office according to claim 30,comprising a plurality of the hybrid operating rooms.